Obesity, Hepatic Insufficiency
Conditions
Brief summary
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.
Interventions
DRUGCP-945,598
Administration of CP-945,598 in subjects with mild hepatic function
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender) * Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.
Exclusion criteria
* All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits * Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits * Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35 | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35 | 14 days |
| Adverse event monitoring throughout duration of the study | 14 days |
| Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14 | 14 days |
| ECGs on Days 1, 7, and 14 | 14 days |
Countries
United States
Outcome results
None listed